Reagecon Diagnostics Ltd

New product development of testing standards for the food industry

The Company

Reagecon Diagnostics Ltd, is one of the largest producers of physical and chemical reference standards in the world and has targeted annual export revenues of €50 million by 2020 and the creation of 40 new jobs over the next 12-24 months. Founded in Shannon in 1990, the Irish-owned company develops, manufactures and exports physical and chemical standards and reagents for laboratories worldwide. The products are developed and manufactured in Shannon and sold through distributors in 150 countries and directly to end users in Ireland and China through Reagecon Diagnostics Ltd’s sales offices in Shannon, Co. Clare, Ireland, and Shanghai, China.
The competitiveness of the European economy and the smooth functioning of international trade depend very much on reliable measurements, which eliminate the need to duplicate or dispute testing data. Accurate and reliable measurements also enhance our quality of life – delivering better healthcare, safer food and a cleaner environment. In order for reliable results to be provided by properly accredited laboratories, they must have access to appropriate standards and methods of measurement. The rapidly changing legislative landscape is leading to dramatic growth in the requirement for testing to prove compliance and so an equally dramatic growth in the requirement for suitable reference materials; this is the opportunity for Reagecon Diagnostics Ltd.

The Question

1. The development and expansion of various oils for food purposes (eg krill oil, rapeseed oil, etc) has resulted in the need for an expanding panel of fatty acid standards to measure these emerging (and existing) products against. A significant consideration in the development of new products is the sustainability of these products, from a raw material and environmental perspective.
2. Phthalates and azo dyes are chemicals that to date have been predominantly controlled within the textiles sector. Phthalates are plasticizers and are added to plastics to increase their flexibility, transparency and durability; azo dyes are a group of pigments added to packaging products and are characterized by their vivid colours. Both these chemical groups have more recently been identified to be of concern in food contact materials. In 2009 the Joint Research Centre of the Institute for Reference Materials and Measurements (European Commission) published a review of methods to measure phthalates in food; they identified 19 different methods being used by laboratories all over Europe with no indication of the measurement of uncertainty for these methods. In addition, while there are methods available for detection of food permitted azo dyes, there is little information regarding the detection of azo dyes used, for example, in the printing of labels for food products (which are not permitted in the food chain). The development of proprietary standards for these chemicals and information as to the prominence of phthalates and azo dyes in the food chain would provide Reagecon Diagnostics Ltd with a significant advantage in a rapidly growing market.

Solution through Shannon ABC

• Microalgae were used as a sustainable source of fatty acids for reference standard development. 52 combinations were screened, resulting in four microalgae and two growth conditions for suitable production of six essential fatty acids (EPA, DHA, DPA, ARA, LA, and GLA) to generate eight types of dietary reference standards.
• Scale up of the four selected microalgae to 20L cultures. The resultant biomass was used to evaluate lipid and fatty acids yield by conventional solvent extraction method.
• Large-scale culture biomass was also used to optimize supercritical CO2 extraction conditions for optimum/enriched extraction of specific fatty acids.
• Additionally, three microalgae and three specific growth conditions were identified for suitable production of fatty acids for a total of six types of biofuel/feed reference fatty acid standards.
• Analytical method developed and validated for the detection of 9 phthalates (DMP, DEP, DBP, DHP, BBP, DBEP, DEHP, DNOP and DINP) with defined linearity, accuracy, limits of quantification and repeatability and determination of phthalate transfer in liquid samples.
• Analytical method developed for 23 azo dyes and breakdown products with defined accuracy values.
• Extraction method for food matrices developed to ensure compound recovery and measurement without interference from sample matrix.
• Stability testing of selected fatty acids samples, azo dyes and phthalates to ensure reference standards would withstand the extremes of temperatures during transportation to customers and storage.
• Technology and method transferred to Reagecon Diagnostics Ltd. The project lead scientist from Shannon ABC trained Reagecon Diagnostics Ltd scientists on-site to ensure successful implementation of project outcomes.

Reagecon Diagnostics Ltd operates a very well defined corporate strategy, in order to deliver its vision. A critical component of this strategy is sustainable competitive advantage. The company has adopted four key business drivers, which if executed properly will propel it ahead of its competitors; these are New Product Development (NPD), Accreditations, Innovative Business Development and Operational Effectiveness and Efficiency. The strategic innovation program with Shannon ABC at LIT will contribute to all of these drivers.
Based on the Innovation Partnership, we will now, as part of our NPD programme, launch in the marketplace standards for Azo- dyes, phthalates, and Fatty Acids. After that we will launch a range of Fatty Acid Methyl and Ethyl Esters targeted at the Biofuel market which will augment our extensive range of existing petrochemical standards. Customers will have an option to buy all of the Fatty Acid standards in Deuterated form as part of an internal standard offering for techniques such as Gas Chromatography and Liquid Chromatography. ISO 17025 and or ISO guide 34 accreditations will then we sought from the Irish National Accreditation Board for all of these families of products. These offerings will be launched formally in our new 400 page catalogue (containing almost 10,000 part numbers) at the Analytica Science exhibition in Munich in May 2016.
The launch will include detailed technical literature and webinar training programmes on all of these new families and several other novel initiatives targeted at our 150 global distributors. The new products will be a central point of focus in our international advertising campaign for 2016 and 2017 and will also be a central point of focus for the launch of our new Global Metrology Centre in October 2016 in Shannon and also our annual International convention held at the same venue.
Finally, we believe the production of Fatty Acids from micro algae to be clean, efficient, environmentally friendly and cost effective. All of these facets of the project feed into our Corporate and Social programs aimed at being efficient, effective and environmentally friendly and we believe we are the only company worldwide using these technologies for standard and reference material production. Overall, we are totally convinced that the output from the project will contribute significantly to business objectives and corporate vision.

Company Testimonial

This project has been our first formal professional interaction with a third level institution for a considerable period. We are very pleased with how the project was scoped, the extreme attentiveness and responsiveness of the team in Shannon ABC, access to college staff at all levels to facilitate understanding of the importance of the project strategically for us and the full time availability of the key researchers to dedicate themselves fully and completely to the project. Timelines, deliverables and milestones were met and all interim reports were comprehensive and succinct. Most importantly, there is compatibility between the size of Shannon ABC, the scale of their operations and the size of a typical SME. Finally, the Hartnett Centre at LIT where most of the work was conducted, is extremely well fitted out with a wide range of instrumentation which expedited rapid and easy access to the relevant equipment and is conducive to rapid turnaround of scientific data. We look forward to more collaboration and performing more research with Shannon ABC for the foreseeable future.
Mr John Barron, Managing Director, Reagecon Diagnostics Ltd